Kornimate/medical-research-clean huggingface dataset:
assessment of response to ncrt for gej cancer using a fully integrated pet/mri

Conditions: Esophageal Cancer; Esophageal Neoplasms

Summary: evaluate the potential role of pet/mri as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (ncrt).

this is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive ncrt (cross regimen) prior to surgery. the study aims to evaluate routine pre-treatment work-up includes pet to stage the tumour extension. * pet/mri (magnetic resonance imaging) will replace the pet component of ct(computed tomography) * an additional intermediate 18-fdg (fluorodeoxyglucose) pet/mri will be performed during ncrt * post ncrt imaging, as required prior to surgery, will be pet/mri six weeks after treatment completion. * 8-12 weeks post ncrt completion surgery will be performed, based on each patient's performance status and response to ncrt * histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.

Eligibility criteria:
inclusion criteria: * biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (ac) or squamous cell carcinoma (scc) for which an ivor-lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated; * visible tumor on pre-treatment imaging; * ≥ 18 years of age; * signed informed consent. exclusion criteria: * - incomplete preoperative imaging assessment; * contraindications to neoadjuvant treatment; * contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents); * inability to complete imaging examinations (i.e. severe claustrophobia); * contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed)); * pregnant or lactating women * severe hypersensitivity to gadobutrol or fludeoxyglucose f18.

Keywords: response neoadjuvant pet/mri radiomics gej cancer
2d strain of right ventricle in peroperative of cardiac surgery

Conditions: Aortic Valve Disorder

Summary: evaluation of the right ventricle (rv) deformation (strain) with 2d speckle tracking technics obtained by echocardiographies (tee) in peroperative period of cardiac surgery . tee is performed for each patient of cardiac surgery during the operation time . this new evaluation parameter of rv could be a good tool to assess the early rv dysfunction after cardiac surgery.

monitoring of 2d strain of right ventricle free wall by tee in perioperative of cardiac surgery : in preoperative time after sternotomy after surgery inclusions of patients elected for aortic valve surgery without coronary diseases or previous rv dysfunction. comparison with others echocardiographic parameters of rv evaluation association with right ventricle insufficiency after cardiac surgery.

Eligibility criteria:
inclusion criteria: * patient eligible for aortic valve surgery exclusion criteria: * previous right ventricle dysfunction * severe coronary disease

Keywords: transesophageal echography perioperative cardiac surgery aortic valve replacement 2d strain of right ventricle
bile omics for diagnosing indeterminate biliary strictures

Conditions: Cholangiocarcinoma; Gallbladder Cancer and Extrahepatic Cholangiocarcinoma; Pancreatic Cancer; Bile Duct Strictures of Unknown Origin; Bile Duct Strictures

Summary: the diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. molecular biological testing techniques based on bile have been reported to improve detection rates. however, whether the combination of bile-based omics studies and biliary brush cytology/biopsy can enhance diagnostic sensitivity has not yet been reported. this study aims to collect bile from patients with malignant biliary strictures, screen for molecular markers associated with biliary malignancies through multi-omics analysis, and subsequently validate these markers to establish a bile-based molecular diagnostic model.


Eligibility criteria:
inclusion criteria: * indeterminate biliary strictures * aged 18-90 years * underwent ercp with biliary biopsy and/or brush cytology exclusion criteria: * coagulation disorders * pregnancy * malignancies of other organs unrelated to biliary strictures * declined participation
sequential hipec of oxaliplatin and paclitaxel for gastric cancer patients with peritoneum metastasis

Conditions: Gastric Cancer; Metastases to Perineum

Summary: the recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. it has been reported by dr.fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (hipec), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. refer to the experience of systematic chemotherapy, hipec with combination regimen would have a brighter prospect. in this study, the investigators would use oxaliplatin and paclitaxel sequent as hipec regimen. the safety and overall survival would be observed and evaluated.


Eligibility criteria:
inclusion criteria: * histologically proved gastric adenocarcinoma. * peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid. * potentially resectable gastric cancer. * alt, ast \ 4x10\^9/l; plt \> 100x10\^9/l; cr \< 1.5 fold normal value. * ecog 0-2 points. * expected survival time longer than 3 months. * informed consent. exclusion criteria: * recurrent gastric cancer. * pregnant or lactating women. * allergic to oxaliplatin or paclitaxel. * abnormal liver/kidney function. * serious heart/metabolic disease.
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for tbi

Conditions: Traumatic Brain Injury

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of traumatic brain injury

studies have shown that stem cell treatment is safe and efficacious for the treatment of traumatic brain injury (tbi). this patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of tbi. patients with tbi will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of traumatic brain injury * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur * seizure disorders

Keywords: traumatic brain injury stem cell treatment
802np301 efficacy and safety study of biib074 in participants with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the primary objective of the study is to evaluate the efficacy of biib074 in treating pain experienced by participants with trigeminal neuralgia (tn). secondary objectives of this study are to investigate the safety and tolerability of biib074 in participants with tn and to evaluate the population pharmacokinetics (pk) of biib074.


Eligibility criteria:
key inclusion criteria: * a diagnosis of trigeminal neuralgia (tn) for at least 3 months based on international headache society (ihs) diagnostic criteria. * participant must have failed at least 1 prior standard of care pharmacologic treatment for tn (defined as an inadequate response or intolerance to treatment), as determined by the investigator based on medical history. * age ≥18 years at the time of informed consent. * allowed concomitant medications must have been stable for at least 4 weeks prior to day 1 of the dose-optimization period. the maximum dosage of carbamazepine allowed on day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine). * participants must have recorded their pain score in their ediary on at least 5 days during the run-in period (days -7 to -1). key exclusion criteria: * history or positive test result at screening for hepatitis c virus antibody or current hepatitis b infection (defined as positive for hepatitis b surface antigen \[hbsag\] and/or hepatitis b core antibody \[hbcab\]). * positive history of human immunodeficiency virus (hiv) or a positive hiv test at screening. * participants with facial pain other than tn. * personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury. * known hypersensitivity to biib074 or components of the biib074 formulation or matching placebo. * positive pregnancy test result at screening (women of childbearing potential only) * has donated blood or blood products within a 30-day period prior to screening. note: other protocol defined inclusion/exclusion criteria may apply
safety and efficacy of the knee-t-nol anterior cruciate ligament (acl) prosthesis

Conditions: Anterior Cruciate Ligament Rupture

Summary: the study is designed to evaluate the safety and efficacy of implanting the tavor acl prosthesis in patients with a ruptured acl by improvement of healing kinetics as well as major adverse treatment events (aes). it is designed to test the hypothesis that there is a difference in healing kinetics of acl deficient knees treated by acl reconstruction using autografts and those in which such procedure was performed with the tavor prosthesis.


Eligibility criteria:
inclusion criteria: 1. patient is \>= 18 years old 2. patient has a ruptured acl 3. operated knee has full range of motion and no swelling 4. patient understands the study requirements and the treatment procedures and rehabilitation and provides written informed consent before any study-specific tests or procedures are performed. 5. the patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic. exclusion criteria: 1. skeletal immaturity 2. pregnancy 3. patient with: * uncontrolled systemic hypertension * severe uncontrolled diabetes mellitus * epiphyses that have not yet closed * periarticular or patella fracture * history of metabolic bone disease (e.g.., osteoporosis, rickets) * crystal deposition disease, e.g., gout * inflammatory joint disease, e.g., rheumatoid arthritis * severe degenerative joint disease * known neoplastic disease * hiv positive * current steroid therapy in excess of prednisone 5 mg/day * other severe, life-threatening systemic disease or any medical condition that interferes with their ability to participate in a rehabilitation program 4. the subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.

Keywords: acl arthroscopy ligament rupture reconstruction aclr accelerated rehabilitation program
compression therapy of the lower limbs in patients with decompensated heart failure

Conditions: Heart Failure

Summary: randomized 1:1 multicenter double-blind clinical investigation evaluating the efficacy and safety of compression therapy of the lower limbs plus parenteral administration of diuretics vs. administration of parenteral diuretics alone (standard treatment) in patients with decompensated hf and predominantly systemic tissue congestion and absence of intravascular systemic congestion. patients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for up to 72 hours. the dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * patient with clinical judgment of acute decompensated heart failure in the first 96 hours from the start of parenteral diuretic treatment. * patient treated with furosemide at least 40 mg in the last 24 hours. * nt-probnp levels\>1000 pg/ml at least 1 time since the onset of decompensation. * presence of tibio-malleolar edema at least grade ii/iv at the time of inclusion. * inferior vena cava (ivc) diameter on ultrasonography ≤21 mm at the time of the "screening" visit. exclusion criteria: * being admitted to the intensive care unit. * renal transplant, chronic renal failure stage 5 (egfr \<15 ml/min/1.73m2) or being included in dialysis program (peritoneal/hemodialysis) or in need of ultrafiltration. * absence of peripheral pulses. * ankle brachial index (abi) \<0.9. * history of severe peripheral artery disease. * previous intolerance to compressive bandaging. * hf secondary to acute myocardial infarction.
a real-world study on golidocitinib-based therapeutic regimens for the treatment of patients with peripheral t-cell lymphoma

Conditions: Peripheral T-cell Lymphoma (PTCL)

Summary: this real-world study aims to evaluate the safety and efficacy of golidocitinib-based treatment regimens in patients with peripheral t-cell lymphoma (ptcl), without intervention in the selection of therapeutic strategies. a total of 1,000 ptcl patients are planned to be enrolled. after screening, eligible participants meeting the inclusion and exclusion criteria will be assigned to one of three predefined cohorts: cohort 1: treatment-naïve patients with ptcl or nk/t-cell lymphoma. cohort 2: patients receiving maintenance therapy following remission after first-line induction treatment for ptcl. cohort 3: patients with relapsed or refractory ptcl or relapsed/refractory nk/t-cell lymphoma. there is no cap on the number of participants in each cohort.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign and acknowledge understanding of the informed consent form 2. clinically confirmed diagnosis of peripheral t-cell lymphoma 3. inclusion of ptcl patients who initiated a golidocitinib-based treatment regimen within the past 3 months 4. compliance with clinical management and provision of disease-related historical medical information required for the study, including but not limited to medical records, treatment history, and prior/prescribed therapeutic regimens exclusion criteria: 1. poor patient adherence 2. investigator-deemed ineligibility for enrollment
csa vs mmc for preventing pterygium recurrence

Conditions: Pterygium; Pterygium of the Conjunctiva and Cornea

Summary: aimed to compare the efficacy and safety of topical cyclosporin a (csa) versus mitomycin c (mmc) as adjunctive therapies in preventing pterygium recurrence after surgical excision.

a total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: group a received topical cyclosporin a, while group b was treated with topical mitomycin c. ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * diagnosed with primary pterygium extending at least 1 mm onto the cornea. * no prior history of pterygium surgery in the affected eye. exclusion criteria: * history of ocular surface diseases such as dry eye or sjögren's syndrome. * active ocular infection. * known hypersensitivity to csa or mmc. * systemic conditions requiring immunosuppressive therapy.

Keywords: pterygium mitimycin c cyclosporin a
metabolic effects of accurate blood sugar results and education in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: a randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education. a systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients. education in smbg combined with a high analytical quality instrument for smbg, introduced in a systematic and thorough way will improve hba1c by 0,5% and keep it over a period of 9 months.

* written informed consent 130 patients with type 1 diabetes to be included * age 18-70 * hba1c of 8% or higher, variation in hba1c over the last 18 months sholuld be \<1,5% * treated with multiple insulin injections or insulin pumps * variation in weight less than 5kg within last year * using smbg on a daily basis * mental capacity and stability to participate * no hypoglycemia unawareness * no likelihood that patient will drop out or not perform according to protocol * continious recruitment from the outpatient clinic at stavanger university hospital from october 2004-october 2005 * 9 months follow-up * possible 12 month extension after initial * intervention group receives new smbg instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. control group continues regular care following national guidelines of norway. this includes visits usually every 3-6 months at the outpatient clinic and possibly with their gp in addition.

Eligibility criteria:
inclusion criteria: * hba1c 8% or higher, less than 1,5% variation within last year * age 18-70 * multiinjections or insulin pumps * stable weight (\<5kg variation last year) * mentally stable exclusion criteria: * hypoglycemia unawareness * mental incapacity

Keywords: hba1c self-monitoring blood glucose (smbg) diabetes treatment quality of care
colorectal cancer in india: catastrophic expenditure and referral pathways influence on presentation and treatment

Conditions: Colorectal Cancer; Treatment Compliance; Health Care Utilization

Summary: observational study to assess barriers for colorectal cancer treatment compliance in india, including quantitative assessment of catastrophic expenditure incidence and qualitative assessment of financial and non-financial barriers.

objective: to identify a vulnerable group of colorectal cancer patients in india who cannot afford or are unable to comply with a treatment plan for colorectal cancer. aims: 1. to identify the proportion of crc patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatment. 2. to determine the proportion of patients who are unable to comply with the treatment plan for crc, at 6 weeks, 3 months and 6 months after diagnosis. 3. to identify barriers and solutions to crc treatment compliance. design: a mixed-methods study comprising quantitative pilot data from 3 tertiary cancer centres and qualitative work from interviews with patients and healthcare professionals. participants: patients diagnosed with primary colorectal cancer. outcomes: primary outcome: • incidence of catastrophic expenditure due to out-of-pocket payments for cancer care at 3 timepoints: 6 weeks, 3 months and 6 months after crc diagnosis. secondary outcomes: * compliance to the initial treatment plan at three timepoints: 6 weeks, 3 months and 6 months after crc diagnosis. * patients and healthcare professionals perspectives on patient compliance to crc treatment. * identify the 5 main drivers (items charged to the patient) of crc treatment cost. * colorectal cancer stage at the time of diagnosis.

Eligibility criteria:
inclusion criteria * adults aged 18+ years old. and * consecutive new patients with a histopathology proven colorectal cancer for whom a crc treatment plan is made: * in an multi-disciplinary team meeting (mdt); * or in the outpatient clinic where an mdt is not available (surgery, oncology or radiotherapy outpatient clinic). and • undergoing treatment in the hospital where the mdt took place exclusion criteria * patients with no histopathology available * telephone follow-up not possible
protocol to obtain blood for discovery of novel biomarkers and potential therapeutic targets in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to collect a blood sample from patients with chronic lymphocytic leukemia (cll) and from volunteers without cll.

the blood sample will be used in the laboratory to perform focused studies on chronic lymphocytic leukemia (cll).

Eligibility criteria:
inclusion criteria: * patients undergoing routine blood draws as part of their ongoing follow-up care for cll at the norris cotton cancer center of dhmc. * normal donors who have no history of active or prior hematologic malignancy. exclusion criteria: * patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their cll, other hematologic malignancy or other disease process within the past 2 months are excluded. use of intravenous immunoglobulin (ivig) is not a reason for exclusion. * normal donors who have a history of steroid use, immunosuppression therapy or autoimmune disease are excluded.

Keywords: chronic lymphocytic leukemia cll normal volunteers
cortisol activity in patients with prader-willi syndrome and healthy controls

Conditions: Prader-Willi Syndrome

Summary: the purpose of the study is to find out if people with prader-willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.


Eligibility criteria:
inclusion criteria: * prader-willi syndrome confirmed by molecular testing, ages 6 months to adult * controls: age-matched, sex-matched, developmentally normal, bmi-controlled healthy or obese subjects exclusion criteria: * pws subjects without molecular confirmation of the diagnosis * subjects receiving glucocorticoid treatment within 3 months of evaluation * subjects receiving growth hormone within one year prior to analysis